Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma

Phase 2

Recruiting

• Conditions: Cardiac Arrest From Trauma
• Interventions: Combination Product: Emergency preservation and resuscitation; Other: Standard resuscitation

• Registration Number: NCT01042015
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.

Detailed Description

The intent of the technique to be studied is to induce a state of hypothermic preservation in trauma victims who have exsanguinated to the point of cardiac arrest. In appropriately selected subjects, after an initial emergency attempt at resuscitation with standard techniques, an arterial catheter will be inserted into the descending thoracic aorta. Using appropriate tubing, pump, and heat exchanger,a large quantity of ice-cold saline (0.9% Sodium Chloride for Injection USP) will be pumped as rapidly as possible into the aorta with the goal of cooling the brain (tympanic membrane temperature, Tty) to \<10 C. If possible, a large venous catheter will be placed and recirculation of fluid established.

Once the subject has been sufficiently cooled, bleeding will be controlled surgically. The subject will then be resuscitated and rewarmed with full cardiopulmonary bypass.

The goal is to improve neurologically-intact survival in these patients.

Study Timeline

• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Study Start: 2016-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Penetrating trauma with clinical suspicion of exsanguinating hemorrhage
• At least 1 sign of life at the scene (pulse, respiratory efforts, spontaneous movements, reactive pupils)
• Loss of pulse <5 min prior to Emergency Department (ED) arrival or in ED or operating room
• ED thoracotomy performed without immediate return of a palpable pulse in the carotid arteries after clamping the descending thoracic aorta

Exclusion Criteria

• No signs of life for >5 min prior to the decision to initiate EPR
• Obvious non-survivable injury
• Suggestion of traumatic brain injury, such as significant facial or cranial distortion
• Electrical asystole
• Rapid external assessment of the injuries suggests massive tissue trauma or blunt trauma involving multiple body regions
• Pregnancy
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emergency preservation and resuscitation	Emergency preservation and resuscitation	These subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass.
Concurrent controls	Standard resuscitation	These subjects would undergo standard resuscitative efforts.

Primary Outcome Measures

Name	Time	Method
The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5).	Hospital discharge

Secondary Outcome Measures

Name	Time	Method
Survival	28 days
Feasibility of initiating EPR (cooling and achieving goal brain temperature)	1 hour
Multiple organ system dysfunction	During the initial hospitalization
Neurologic functional outcome	12 months

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States